Study of Red Bull™ Sugar-Free Drink for Reduction of Fatigue in Prostate Cancer Patients Receiving LHRH Agonist Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01669460
First received: August 16, 2012
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

The purpose of this research study is to find out if Red Bull™ Sugar-Free Drink can reduce fatigue in prostate cancer patients receiving LHRH agonist therapy.


Condition Intervention Phase
Fatigue
Other: Red Bull™ Sugar-Free Drink
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Phase II, Open Label Study of Red Bull™ Sugar-Free Drink for Reduction of Fatigue in Prostate Cancer Patients Receiving LHRH Agonist Therapy

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Reduction in overall fatigue as measured by Bruera global fatigue severity scale. [ Time Frame: Within 4 days after completion of intervention (28 days of Red Bull™) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall improvement in quality of life as measured by the Medical Outcomes Study Short-Form (SF-36) [ Time Frame: Within 4 days after completion of intervention (28 days of Red Bull™) ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: July 2012
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Red Bull™ Sugar-Free Drink
Red Bull™ Sugar-Free Drink: two (250mL) cans per day for 28 days
Other: Red Bull™ Sugar-Free Drink
Red Bull™ Sugar-Free Drink two (250mL) cans per day for 28 days

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed prostate cancer
  • Currently receiving LHRH-agonist therapy for greater than 6 months
  • Measurable fatigue, defined as a score of ≥ 2 on the Bruera global fatigue severity scale
  • Able to swallow Red Bull™ Sugar-Free Drink
  • Life expectancy of at least 1 year
  • Able to read and write in English
  • Willing to limit consumption of alcohol to one drink per day

Exclusion Criteria:

  • Current malignancy or received treatment for a previous malignancy within the last 3 years other than prostate cancer (exceptions are superficial bladder cancer or non-melanoma skin cancer)
  • Myocardial infarction within past 6 months
  • Any unstable serious co-existing medical condition(s) including but not limited to unstable or poorly controlled coronary artery disease, chronic atrial fibrillation, uncontrolled hypertension, uncontrolled diabetes, severe bleeding diseases or immune disorders
  • Evidence of drug or alcohol abuse
  • Known hypersensitivity to caffeine
  • Known history of liver and kidney insufficiencies
  • Known contraindications to Red Bull™ use
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01669460

Locations
Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5T 1C1
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Neil Fleshner, MD, FRCSC, MPH University Health Network, Toronto
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01669460     History of Changes
Other Study ID Numbers: 12-5041-C
Study First Received: August 16, 2012
Last Updated: December 18, 2013
Health Authority: Canada: University Health Network Research Ethics Board

Additional relevant MeSH terms:
Fatigue
Prostatic Neoplasms
Signs and Symptoms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 16, 2014